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OpenTrials
Completed

NCT Number: NCT03796221

Parenting Intervention for Pediatric Obesity

The purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Legal guardian of a new patient to the Nemours pediatric obesity clinic
  • Child with body mass index (BMI) greater than the 95th percentile for age and sex
  • Child 4-11 years of age

Exclusion criteria

  • Not proficient in English or Spanish
  • Not able to access the internet on any type of device
  • Child has a genetic syndrome or primary endocrine disorder associated with obesity
  • Child is taking a medication known to impact weight

Treatment and study plan

Parenting videos

Behavioral

Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.

Standard pediatric obesity treatment

Behavioral

Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.

Primary outcomes

  1. Change in child weight status

    Time frame: 6 months

    Change in child BMI-z score

  2. Change in child weight status

    Time frame: 6 months

    Change in child BMI percentile (referenced to the 95th percentile)

  3. Change in caregiver confidence managing child lifestyle behaviors

    Time frame: 6 months

    Change in Lifestyle Behavior Checklist Confidence score

  4. Change in child lifestyle behaviors

    Time frame: 6 months

    Change in Lifestyle Behavior Checklist Problem score

Secondary outcomes

  1. Discussion of parenting topics during visits to the pediatric obesity clinic

    Time frame: 1 month, 2 months, 3 months, 6 months

    Discussion helpfulness ratings at each visit

  2. Change in child weight status

    Time frame: 3 months

    Change in child BMI-z score

  3. Change in child weight status

    Time frame: 3 months

    Change in child BMI percentile (referenced to the 95th percentile)

  4. Change in caregiver confidence managing child lifestyle behaviors

    Time frame: 3 months

    Change in Lifestyle Behavior Checklist Confidence score

  5. Change in child lifestyle behaviors

    Time frame: 3 months

    Change in Lifestyle Behavior Checklist Problem score

Sponsors and collaborators

Lead sponsor

Nemours Children's Health System

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Integrating Parenting Interventions Into Pediatric Obesity Care

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2019
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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